Pelican Plasma

Summary Statement of Deficiencies D0000 A Certification survey was performed on September 19, 2023 at Pelican Plasma, CLIA ID # 19D2218184. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and proficiency testing records as well as interview with personnel, the laboratory failed to ensure testing personnel signed the attestation statements for six (6) of six (6) proficiency testing (PT) events reviewed in 2022 and 2023. Findings: 1. Review of the laboratory's "Proficiency Testing" policy under "Survey Testing" revealed "Individual(s) performing proficiency testing will sign the test result form attesting the survey was completed in accordancd with the CLIA '88 requirements". 2. Review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing (PT) records from 2022 and 2023 revealed the attestation statements were not signed by testing personnel for the following six (6) of six (6) PT events reivewed: a) AAB Chemistry M1 2022 b) AAB Chemistry M2 2022 c) AAB Chemistry M3 2022 d) AAB Chemistry M1 2023 e) AAB Chemistry M2 2023 f) AAB Chemistry M3 2023 3. In interview on September 19, 2023 at 226 pm, Quality and Regulatory Services Personnel stated that testing personnel signed the raw data after their performance. Quality and Regulatory Services Personnel confirmed the attestations were not signed by testing personnel as required by laboratory policy. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: I. Based on review of the laboratory's policies, personnel records and interview with personnel, the laboratory failed to follow their established competency assessment policies for three (3) of three (3) testing personnel performing total protein testing. Findings: 1. Review of the laboratory's "Competency Evaluation" policy revealed "The competency evaluation for each area must include direct observation of critical job functions and/or testing of academic knowledge. The following items may be performed to complete the evaluation: * Direct observation of routine donor/patient test performance, including preparation, if applicable, specimen handling, processing, and testing. * Monitoring the recording and reporting of test results. * Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records * Direct observation of performance of instrument maintenance and function checks. * Assessment of test performance through testing of previously analyzed specimens, internal blind testing samples, or external proficiency testing samples. * Assessment of problem solving skills. Individuals who fall under a CLIA regulated testing category must have the first 6 elements listed above included in their competency evaluation. Competency evaluation records shall include a listing of all critical elements required to complete a task. Criteria shall be included that establish the minimum acceptable performance required to successfully complete the evaluation". 2. Review of personnel records for 2022 and 2023 revealed the laboratory did not have documentation of a competency assessment that included the required six (6) parts for the following three (3) of three (3) testing personnel reviewed: a) Personnel 2 b) Personnel 3 c) Personnel 4 3. In interview on September 19, 2023 at 1:41 pm, Quality and Regulatory Services personnel confirmed the laboratory did not follow the established policy for the identified testing personnel. II. Based on review of the laboratory's policies and interview with personnel, the laboratory failed to establish a complete written competency assessment policy for testing personnel. Findings: 1. Review of the laboratory's policy for Competency Evaluation revealed the laboratory did have a competency assessment policy which included the six (6) requirements and frequency of performance for testing personnel; however, the policy did not include which personnel performs competency assessments for testing personnel based on their qualifications. 2. In interview on September 19, 2023 at 1:41 pm, Quality and Regulatory Services personnel confirmed the laboratory policy did not have the delegation of performance for competency assessments. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 An Initial survey was performed on January 31, 2022 at Pelican Plasma, CLIA ID # 19D2218184. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: I. Based on review of the laboratory policy, personnel records and interview with personnel, the laboratory failed to follow their established competency policy for two (2) of two (2) testing personnel reviewed. Findings: 1. Review of the laboratory's competency assessment policy revealed the laboratory performs an initial assessment, six (6) month assessment and an annual assessment thereafter upon hiring of testing personnel. 2. Review of personnel records revealed the laboratory did not perform an initial or a six (6) month assessment for the following one (1) of two (2) testing personnel reviewed: a) Testing Personnel 2 3. Further review of personnel records revealed the laboratory did not have Laboratory Director/Technical Consultant approval/signature for the following one (1) of two (2) testing personnel reviewed: a) Testing Personnel 3 3. In interview on January 31, 2022 at 12:20 pm, Personnel 2 stated she was unaware that a competency assessment was required since she normally does not perform patient testing. Personnel 2 further stated that a competency assessment was completed for Personnel 3 but the assessment was not performed by qualified personnel. Personnel 2 confirmed the above identified testing personnel did not have completed competency assessments. II. Based on review of laboratory policy, personnel records and interview with personnel, the laboratory failed to ensure that a competency assessment policy was included for the assessment Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- for the Technical Consultant. Findings: 1. Review of laboratory policy and procedure manual revealed the laboratory did not include a policy for the assessment of the duties and responsibilities along with the frequency of performance for the Technical Consultant. 2. Review of personnel records revealed the laboratory did not include a competency assessment for Personnel 4 who serves as the Technical Consultant. 3. In interview on January 31, 2022 at 12:20 pm, Personnel 2 confirmed the laboratory did not have a competency assessment policy or perform an assessment for the identified personnel. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of laboratory's policy and procedure manual and interview with personnel, the laboratory failed to establish a written, detailed procedure for all aspects of testing. Findings: 1. Review of the laboratory's policies revealed the laboratory did not have written, detailed instructions for the following: a) Proficiency Testing: to include but not all inclusive of how to test proficiency samples, analyzer utilized for testing or a twice a year verification for other analyzers, who is responsible for proficiency testing reviews and assessment of unacceptable results, and how often proficiency testing samples are tested. 2. In interview on January 31, 2022 at 11:00 am, Personnel 2 confirmed the laboratory did not include the identified above policy. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of the laboratory's CMS-209 (Laboratory Personnel Report) and personnel records as well as interview with personnel, the Laboratory Director failed to ensure Testing Personnel had appropriate training documentation prior to patient testing. Findings: 1. Review of the laboratory's CMS-209 (Laboratory Personnel Report) and personnel records revealed the following testing personnel did not have documentation of the Laboratory Director's approval/signature for patient testing: a) Personnel 2 b) Personnel 3 2. In interview on January 31, 2022 at 12:20 pm, Personnel -- 2 of 4 -- 2 confirmed the laboratory did not have documentation of initial training for the identified testing personnel approved/signed by the Laboratory Director prior to performing patient testing. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on review of laboratory policy, personnel records and interview with personnel, the Laboratory Director failed to ensure policies and procedures for assessing personnel competency were established. Findings: 1. The laboratory failed to follow their established competency policy for two (2) of two (2) testing personnel reviewed. Refer to D5209 I. 2. The laboratory failed to ensure that a competency assessment policy was included for the assessment for the Technical Consultant. Refer to D5209 II. 3. The Technical Consultant failed to evaluate competency annually for two (2) of two (2) testing personnel reviewed. Refer to D6054. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on review of laboratory policy and procedure manual and interview with laboratory personnel, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel. Findings: 1. The laboratory failed to establish a complete policy and procedure manual. Refer to D5403. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on review of laboratory policy, personnel records and interview with personnel, the Technical Consultant failed to evaluate competency annually for two (2) of two (2) testing personnel reviewed. Findings: 1. Review of laboratory policy revealed the laboratory performs testing personnel competency assessments upon initial hire, at six (6) months and then annually thereafter. 2. Review of personnel records revealed the laboratory did have documentation of an initial and six (6) month assessment for Personnel 3; however, the personnel records did not have documentation to show Laboratory Director/Technical Consultant approval/signature for Personnel 3. 3. Further review of personnel records revealed the laboratory did not have documentation of initial and six (6) month competency assessment with Laboratory Director/Technical Consultant approval for Personnel 2. 4. In interview on January 31, 2022 at 12:20 pm, Personnel 2 confirmed the initial and six (6) month competency assessments were not performed or completed by qualified personnel. -- 4 of 4 --